FDA.reportPublic FDA data

Duet®

Primary DI
00613994445384
Brand
Duet®
Company
MEDTRONIC PS MEDICAL, INC.
Model
46915
Device description
EDMS 46915 DUET INTERLINK WITH VCATH
Published
2015-07-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWMDEVICE, MONITORING, INTRACRANIAL PRESSURE
JXGShunt, central nervous system and components
PCBExternal cerebrospinal fluid (CSF) diversion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWMDevice, Monitoring, Intracranial PressureNeurology2
JXGShunt, Central Nervous System And ComponentsNeurology2
PCBExternal Cerebrospinal Fluid (Csf) DiversionNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K984053000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K984053000BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEMMedtronic PS Medical1999-02-04JXG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994445384PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994445384006139944453846139944453840613994445384

GMDN Terms#

Term, Definition table
TermDefinition
Ventricular cerebrospinal fluid drainage kitA collection of sterile devices that includes an externally-placed tube intended to be attached to an intracerebral catheter to enable drainage and measurement of cerebrospinal fluid (CSF), and other fluids of similar physical character, as a means of reducing/maintaining intracranial pressure (ICP) and CSF volume. The kit enables removal of CSF from a brain ventricle. It typically consists of a combination of tubes, an attached exchange bag, and a drip chamber connected to an intracerebral catheter. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
089055867
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20763000467382NA464402024-02-26
00763000406080NA273022024-02-26
00763000624798Duet®469162022-03-10
00763000624804Duet®469172022-03-10
00763000406028Duet®469172021-02-07
00763000396008Duet®469152021-01-24
00763000343149N/A200342020-04-20
00763000029449N/A8023 B2020-03-07
00763000030827N/A250772020-03-08
00643169483316NA8023 B2015-06-24
00643169498365NA250772015-07-14
00643169507517NA8023 A2015-06-25
00643169073623NA250772015-06-25
00643169466142N/A461412015-07-15
00673978228969NA464222015-06-18
00673978246017NA272972015-07-21
00673978246031NA273022015-07-14
20643169466122N/A464402015-07-15
00763000422646StrataMR246955MR2026-03-13
00763000422684StrataMR246957MR2026-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03701813000023Catheter Extension CableSOPHYSAGWM2026-10-27
03701813000030PRESSIO® 3 - PATIENT MONITOR EXTENSION CABLE - 3 PARAMETERS (ICP, ICT, MAP)SOPHYSAGWM2026-10-27
03701813000054Catheter Extension CableSOPHYSAGWM2026-10-27
03760409441510PRESSIO® 3 - PATIENT MONITOR EXTENSION CABLE - 3 PARAMETERS (ICP, ICT, MAP)SOPHYSAGWM2026-10-27
03760409441527PRESSIO®3 - PATIENT MONITOR CABLE PHILIPS, AGILENT, MINDRAY 12 pinsSOPHYSAGWM2026-10-27
03760409441534PRESSIO®3 - PATIENT MONITOR CABLE DRAEGER, SIEMENS 10 pinsSOPHYSAGWM2026-10-27
03760409441541PRESSIO®3 - PATIENT MONITOR CABLE SPACELAB, MINDRAY 6 pinsSOPHYSAGWM2026-10-27
03760409441558PRESSIO®3 - PATIENT MONITOR CABLE GE DATEX OHMEDA 10 pinsSOPHYSAGWM2026-10-27
03760409441565PRESSIO®3 - PATIENT MONITOR CABLE GE SOLAR, MARQUETTE 11 pinsSOPHYSAGWM2026-10-27
03760409441572PRESSIO®3 - PATIENT MONITOR CABLE NIHON KOHDEN 5 pinsSOPHYSAGWM2026-10-27
03760409441589PRESSIO®3 - TEMPERATURE PATIENT MONITOR CABLE PHILIPS, AGILENT 2 pinsSOPHYSAGWM2026-10-27
03760409441596PRESSIO®3 - TEMPERATURE PATIENT MONITOR CABLE DRAEGER, SIEMENS 7 pinsSOPHYSAGWM2026-10-27
03760409441602PRESSIO®3 - TEMPERATURE PATIENT MONITOR CABLE SPACELAB 10 pinsSOPHYSAGWM2026-10-27
03760409441619PRESSIO®3 - TEMPERATURE PATIENT MONITOR CABLE GE SOLAR, MARQUETTE, DATEX-OHMEDASOPHYSAGWM2026-10-27
03760409441626PRESSIO®3 - TEMPERATURE PATIENT MONITOR CABLE DATEX-OHMEDA, NIHON KOHDEN, MINDRASOPHYSAGWM2026-10-27
03760409441633PRESSIO®3 - TEMPERATURE PATIENT MONITOR CABLE ARTIC SUNSOPHYSAGWM2026-10-27
03760409441640PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE PHILIPS Jack 3,5mmSOPHYSAGWM2026-10-27
03760409441657PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE DRAEGER INFINITYSOPHYSAGWM2026-10-27
03760409441671PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE GE without patient data moduleSOPHYSAGWM2026-10-27
03760409441688PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE GE CARESCAPE & GE with patient data moduSOPHYSAGWM2026-10-27
03760409441695PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE MINDRAY BENEVIEW T6 & UMEC SERIES 8, 10,SOPHYSAGWM2026-10-27
03760409441701PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE MINDRAY PASSPORT 8, 12 & EPM 10, 12SOPHYSAGWM2026-10-27
03760409441718PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE MINDRAY BENEVIEW N1, N12, N15, N17, N19,SOPHYSAGWM2026-10-27
03760409441725PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE NIHON KOHDEN LIFE SCOPE PT, LIFE SCOPE VSOPHYSAGWM2026-10-27
03760409441732PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE NIHON KOHDEN LIFE SCOPE PT with YJ-920PSOPHYSAGWM2026-10-27
03760409441749PRESSIO®3 - MULTI-PARAMETER NEUROMONITOR ICP, ICT, CPPSOPHYSAGWM2026-10-27
03760409442074PRESSIO®3 - PATIENT MONITOR CABLE SPACELAB 10 pinsSOPHYSAGWM2026-10-27
03760409442081PRESSIO®3 - PATIENT MONITOR CABLE NIHON KOHDEN 14 pinsSOPHYSAGWM2026-10-27
03760409442098PRESSIO®3 - PATIENT MONITOR CABLE FUKUDA DENSHI 12 pinsSOPHYSAGWM2026-10-27
03760409442104PRESSIO®3 - PATIENT MONITOR CABLE FUKUDA DENSHI 11 pinsSOPHYSAGWM2026-10-27